New Apple Watch blood pressure feature gains FDA approval

Elevated blood pressure or hypertension is now estimated to affect nearly half of all US residents, and the latest research suggests that a timely diagnosis is significantly associated with the reduced risk of a cardiovascular event such as a stroke or a myocardial infarction.

Apple has introduced the ability to detect signs of the condition with its latest flagship Watches, although it did so in the absence of regulatory approval.

Now, however, the wearables' Hypertension Notifications will be officially FDA-cleared on their roll-out from next week (starting September 15, 2025).

The Notifications are intended to be made available in ~150 countries worldwide over time. They have debuted in the new Watch Ultra 3 and Series 11 (now starting at $399 on Amazon), although Apple has announced that they will also become active on the Series 9 and 10, as well as the Ultra 2, when they upgrade to watchOS 26.

Apple asserts that the Notifications have been developed with the help of advanced machine learning trained on data extracted from "over 100,000 participants" over multiple studies, then tested in a ~2,000-participant clinical trial.

All the same, the company recommends that their appearance should be backed up by the results of a 7-day blood pressure evaluation using dedicated medical equipment assessed by a medical practitioner in order to constitute a diagnosis of hypertension.